Preview Newsletter
Ethicon 4/15
-
Grand Jury Convened to Look into Criminal Charges Against Boston Scientific Over Counterfeit mesh
Apr 14, 2016 | Mesh Medical Device News Desk
A grand jury in Charleston, W.V. will determine whether BSC engaged in deceptive trade practices by knowingly receiving substandard polypropylene resin from China and then sold that defective product to women and their doctors. -
Boston Scientific faces grand jury probe over allegedly counterfeit material for vaginal mesh
Apr 14, 2016 | Fierce Medical Devices
By Emily Wasserman
Boston Scientific ($BSX) is facing more pushback in its legal saga over vaginal mesh implants. Federal prosecutors are convening a grand jury to consider evidence that the company used defective counterfeit raw materials from China for its devices. -
Report: Feds impanel grand jury in Boston Scientific pelvic mesh probe
Apr 14, 2016 | Mass Device
By Brad Perriello
A federal probe into allegations that Boston Scientific (NYSE:BSX) used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out several subpoenas. -
Boston Scientific Faces Criminal Investigation over Counterfeit Mesh
Apr 14, 2016 | Legal Reader
By Jay W. Belle Isle
Boston Scientific is finally facing greater heat over allegations that it used substandard material in its vaginal mesh implants. Federal prosecutors have impaneled a grand jury in Charleston, West Virginia as Boston Scientific faces criminal investigation over counterfeit mesh. -
Thousands of Federal Lawsuits Pending
Apr 14, 2016 | Drug Watch
By Michelle Llamas
For the past several years, Boston Scientific has also been fighting thousands of lawsuits filed by women who say the company’s transvaginal mesh implantscaused them serious permanent injuries.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Grand Jury Convened to Look into Criminal Charges Against Boston Scientific Over Counterfeit mesh
Apr 14, 2016 | Mesh Medical Device News Desk
A grand jury in Charleston, W.V. will determine whether BSC engaged in deceptive trade practices by knowingly receiving substandard polypropylene resin from China and then sold that defective product to women and their doctors.
Multiple subpoenas have been sent out, reports theGlobe, though a Boston Scientific spokeswoman says the company has not received one.
In a February 24 regulatory filing, BSC said the US attorney’s office in West Virginia was looking into the allegations of defective mesh resin.
The Houston-based Mostyn law firm in January accused the company of running an international conspiracy to sell defective mesh. The Marlborough, Massachusetts-based BSC denies that.
The lawsuit seeks class-action status on behalf of about 55,000 women who have received the pelvic mesh implants since September 2012, the date after which the Chinese-sourced polypropylene resin would have been used. The case is Teresa Stevens. V. Boston Scientific Case no. 2:16-cv-00265).
BSC is working to test its pelvic mesh implants crafted allegedly from the Chinese-sourced mesh to see if it contains high levels of selenium, a trace element that can be toxic at high levels. The firm had a Boston polymer lab test the raw resin and found it contained high levels of selenium. “As a rare and toxic element, this result is unusual and should be verified by using another technique, such as SEM-EDS,” said the report.
The Food and Drug Administration acknowledged the allegations filed in the RICO action but did not recommend that women have their mesh implants removed.
Mostyn law said when BSC lost its US supplier of raw polypropylene, it turned to a known counterfeiter in China. Mostyn says the company acted like a drug dealer then to hide 37,000 pounds of the substandard resin from customs agents in the U.S. and China.
Yesterday in a letter to the FDA and Health and Human Services, Amber Mostyn urged the FDA to pursue criminal charges with the Department of Justice and not just compare old pelvic mesh implants to new ones.
Amber Anderson Mostyn
“The FDA‘s investigation should not be into the quality of the raw material, but rather the source of the raw material. Allowing the defense of equivalence undermines the public policy positions articulated in the very statutes Congress passed to prevent this type of criminal conduct.”~Amber Mostyn
Criminal penalties for smuggling counterfeit material and endangering public health can range from 20 years in prison for serious bodily harm to life in prison for death and a $15 million corporate fine.
The law firm points to documentation that was lacking in the imported material or sourced the material from two different Chinese suppliers. The low-cost material, lower than market value, was split into separate shipments and sent to different ports.
Boston Scientific reports net sales for its urology and pelvic health products were $693 million at the end of 2015, an increase of 30 percent over the prior year.
The company is facing almost 21,000 product liability lawsuits filed in multidistrict litigation, one of seven mesh manufacturers consolidated in one federal court in Charleston, WV.
-
Boston Scientific faces grand jury probe over allegedly counterfeit material for vaginal mesh
Apr 14, 2016 | Fierce Medical Devices
By Emily Wasserman
Boston Scientific ($BSX) is facing more pushback in its legal saga over vaginal mesh implants. Federal prosecutors are convening a grand jury to consider evidence that the company used defective counterfeit raw materials from China for its devices.
A grand jury in Charleston, WV, has sent out multiple subpoenas recently seeking documents about Boston Scientific's purchase of a type of synthetic resin used in mesh implants, The Boston Globe reports. Investigators in the U.S. Department of Justice (DOJ) want to see if the Marlborough, MA-based company knowingly got substandard resins from China that were cloaked in materials approved by regulators, and then sold them to healthcare providers.
Allegations against the company regarding counterfeit mesh products cropped up earlier this year. In January, a Houston-based law firm accused Boston Scientific of allegedly smuggling materials out of China to use in its mesh devices.
Mostyn Law in a suit filed in a West Virginia federal court said that Boston Scientific ran an "international conspiracy" and racketeering operation to get counterfeit supplies for its mesh devices. The company bought "unverified, substandard material from a known counterfeiter" in China, "at times acting like a drug dealer" to cover up multiple overseas shipments, the firm said at the time.
Now, Mostyn Law is seeking unspecified damages for thousands of women who got a Boston Scientific mesh implant after September 2012. According to the firm's tally, that number comes to as many as 55,000 women a year.
Boston Scientific said that it's working with regulators to clear up the issue. The company has voluntarily handed over information requested by the DOJ, spokeswoman Kelly Leadem told the Globe. Boston Scientific hasn't gotten a subpoena, she said, although the company in a recent regulatory filing revealed that the U.S. attorney's office in West Virginia was reviewing claims of defective mesh resin.
Boston Scientific is also defending its product's safety. The company "does not use 'counterfeit' or 'adulterated' materials in our medical devices," Leadem told the Globe in an email. And Boston Scientific has a "robust quality system and dedication to patient safety," she said. "We stand behind our products, the materials used in those products and our commitment to women's health."
Still, the latest news does little to detract from Boston Scientific's problems related to vaginal mesh devices. Earlier this month, the FDA said that it was looking into allegations that substandard materials were used in the company's urogynecologic surgical mesh. The agency stopped short of recommending that the implants be removed, though, because "available data do not suggest any decreased benefit associated with the device," it said, as quoted by the Globe.
Meanwhile, Boston Scientific faces a swath of lawsuits over claims that its vaginal mesh products caused health problems in women. In 2015, the company paid $119 million to settle 3,000 suits. But Boston Scientific still is dealing with thousands of other cases, which are consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.
-
Report: Feds impanel grand jury in Boston Scientific pelvic mesh probe
Apr 14, 2016 | Mass Device
By Brad Perriello
A federal probe into allegations that Boston Scientific (NYSE:BSX) used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out several subpoenas.
The accusations 1st surfaced in January with the filing of a purported class-action racketeering lawsuit in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.
Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans. Lawyers for Stevens laterpetitioned the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.
The subpoenas sent by the grand jury in the Mountain State seek documents related to the purchase of the resin, 2 unnamed sources told the Boston Globe.
“Among other things, 1 of the people said, investigators are examining whether the Marlborough medical device company engaged in deceptive trade practices by knowingly receiving substandard resins from China in packaging from a vendor whose materials had been approved by federal regulators, and whether it fraudulently sold defective products to health care providers,” the newspaper reported.
Boston Scientific spokeswoman Kelly Leadem told MassDevice.com in March that the company “does not use counterfeit or adulterated materials in our medical devices.”
“The company rejects the contrary allegations in the petition” filed by Stevens’s lawyers, Leadem told us. Boston Scientific has not received a subpoena but is cooperating with the U.S. Justice Dept., she told the Globe.
In a statement released April 1 after the FDA revealed that it too is investigating the matter, the company said it’s dedicated to patient safety and backs that up with a robust quality system.
“Changing suppliers of raw materials is not unusual for medical device companies, and when Boston Scientific makes such a change, we follow the processes required by our quality system,” Boston Scientific said. “In 2011, we located a new supplier of Marlex resin. Upon doing so, we put samples of the resin through a rigorous battery of tests to demonstrate equivalency. In addition, we conducted extensive mechanical tests to ensure that our mesh products manufactured with the newly sourced material met product specifications.
“We have the highest confidence in the safety of our mesh devices. We have shared our test data with the FDA, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests,” the company said.
http://www.massdevice.com/report-feds-impanel-grand-jury-boston-scientific-pelvic-mesh-probe/
-
Boston Scientific Faces Criminal Investigation over Counterfeit Mesh
Apr 14, 2016 | Legal Reader
By Jay W. Belle Isle
Boston Scientific is finally facing greater heat over allegations that it used substandard material in its vaginal mesh implants. Federal prosecutors have impaneled a grand jury in Charleston, West Virginia as Boston Scientific faces criminal investigation over counterfeit mesh. It’s about time! The affected mesh has been implanted into thousands of women across the U.S.
Several subpoenas have been sent out over the last few months. The grand jury is not empowered to determine BS’ guilt or innocence; its purpose is merely to compel the production of evidence, whether documents or testimony, such that it can decide whether pressing criminal charges is appropriate. If one was an executive at BS right now, one would be sweating bullets.
The information about the subpoenas comes from two sources, speaking anonymously as they weren’t authorized to discuss the probe. One of the subpoenas was obtained by the Boston Globe. That subpoena demands BS produce documents regarding the company’s purchase of certain synthetic resin used to manufacture the mesh implants.
One of the anonymous sources also said that federal investigators are attempting to determine if BS employed deceptive trade practices in the purchase of the counterfeit mesh. Specifically, the question is whether the company knew it was buying substandard Chinese resins that were put in packaging from another, U.S.-approved, vendor. Further, the investigation seeks to determine if BS knowingly and fraudulently sold the substandard, defective mesh devices to healthcare providers.
Boston Scientific spokesperson Kelly Leadem said that the company voluntarily provided the Department of Justice with the requested documents. However, she said, the company has not yet been subpoenaed.
Transvaginal mesh devices are commonly used to repair a condition known as pelvic organ prolapse or POP. The condition occurs when the bladder drops from the lower abdomen and presses against the vaginal walls. However, mesh devices have been linked to several other, more serious, health problems.
Among the new health problems created by the devices are infections, bleeding, severe pain & discomfort, urinary issues and painful intercourse. Affected women have taken to social media campaigning for the removal of the devices from the market. There are also thousands of product liability suits against BS andother mesh manufacturers.
The cases have been consolidated into a multidistrict litigation (MDL) being overseen by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.
The issue of counterfeit resins became public in January after Houston-based Mostyn Law filed suit against Boston Scientific claiming that BS basically ran and “international conspiracy” as well as a racketeering scheme to fraudulently sell substandard, defective mesh.
The Mostyn suit claims that Boston Scientific lost its U.S. resin supplier, at which point it sought out a known Chinese counterfeiter. The suit further claims that BS was “acting like a drug dealer” by hiding roughly 33,000 pounds of the bogus resin shipments from U.S. and Chinese customs agents by putting it in packaging from a federally-approved vendor.
BS’ CFO, Daniel J. Brennan, mentioned the Mostyn suit in a February 4 conference call with stock analysts. He said BS had given the FDA, the DOJ and health & safety regulators in Europe, all of the information they requested. However, he did not mention the federal investigation or the grand jury.
Then, in a February 24 regulatory filing, BS stated that the U.S. Attorney’s Office in West Virginia was checking into the counterfeit resin claims. To date, federal prosecutors have not accused Boston Scientific of doing anything wrong.
An email statement from Ms. Leadem said, “Boston Scientific does not use ‘counterfeit’ or ‘adulterated’ materials in our medical devices. Boston Scientific has a robust quality system and dedication to patient safety. We stand behind our products, the materials used in those products and our commitment to women’s health.”
However, BS is now working with the FDA testing the safety and efficacy of its mesh devices in an effort that is expected to go on for a few more months. An effort, by the way, that has drawn much criticism given the fact that BS has a motivated self-interest in showing the products are safe.Image courtesy of Roger Ferris/Twitter.
The FDA issued a safety alert on April 1 stating that the agency was investigating claims of substandard materials in BS’ urogynecologic surgical mesh products. The agency didn’t go so far as to suggest that women get the devices removed, though. Instead, the FDA said that it didn’t know of any safety issues specifically caused by the counterfeit resin. It further noted that “available data do not suggest any decreased benefit associated with the device.”
This investigation is good news for the thousands of women whose health has been all but destroyed by pelvic mesh products. While different from the civil suits over injuries caused by the mesh in general, criminal charges (and especially a conviction) could strongly bolster the civil cases by showing Boston Scientific’s utter disregard for patient safety.
-
Thousands of Federal Lawsuits Pending
Apr 14, 2016 | Drug Watch
By Michelle Llamas
For the past several years, Boston Scientific has also been fighting thousands of lawsuits filed by women who say the company’s transvaginal mesh implantscaused them serious permanent injuries.
Doctors use these implants to treat incontinence and pelvic organ prolapse in women, but many patients report complications such as painful sex, organ perforation, excessive bleeding and nerve damage. More than 19,000 lawsuits are pending in West Virginia before Judge Joseph R. Goodwin.
The company’s ProtoGen was the first mesh sling manufactured, but it was later removed from the market in 1999 for safety concerns. The FDA approved a number of mesh products on the market based on the ProtoGen.
Boston Scientific lost millions to jury verdicts and settlements, including settling 3,000 mesh cases for about $119 million last year.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested